510(k) K003328 ยท GIZ Plasma, Control, Normal
ACCUCLOT CONTROL I, MODEL A4089
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Mar 1, 2001 |
| Received | Oct 24, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003328
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.